Rinvoq (Upadacitinib) – All in One Drug to Treat Inflammatory Skin Conditions

RINVOQ is used for the treatment of adults with moderately to severely active rheumatoid arthritis who didn’t respond to one or more TNF blockers.

Limitations of Use: RINVOQ shouldn’t be used in combination with other biologic disease-modifying antirheumatic drugs (DMARDs), JAK inhibitors, or with potent immunosuppressants such as azathioprine and cyclosporine.

RINVOQ is used for the treatment of adults with active psoriatic arthritis who didn’t respond to one or more TNF blockers.

Limitations of Use: Use of RINVOQ in combination with other biologic DMARDs, JAK inhibitors, or with potent immunosuppressants such as azathioprine and cyclosporine.

RINVOQ is used for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies are inadvisable.

Limitations of Use: RINVOQ shouldn’t be used in combination with other biologic immunomodulators, JAK inhibitors, or other immunosuppressants.

RINVOQ is used for the treatment of adult patients with moderately to severely active ulcerative colitis who didn’t respond to one or more TNF blockers.

Limitations of Use: RINVOQ shouldn’t be used in combination with other biological therapies for ulcerative colitis, JAK inhibitors, or potent immunosuppressants such as azathioprine and cyclosporine.

RINVOQ is used for the treatment of adults with active ankylosing spondylitis who didn’t respond to one or more TNF blockers.

Limitations of Use: RINVOQ shouldn’t be used in combination with other biologic DMARDs, JAK inhibitors, or with potent immunosuppressants such as azathioprine and cyclosporine.

It is not known if RINVOQ is safe and effective in children with juvenile psoriatic arthritis, ulcerative colitis, idiopathic arthritis, or ankylosing spondylitis.

• are being treated for an infection, have an infection that keeps coming back, that won’t go away, or think if you have symptoms of an infection.

• Have TB or have been in close contact with someone with TB.

• Have had herpes zoster (shingles).

• Have had hepatitis B or C, blood clots in the veins of your legs or lungs, or cancer.

• if you live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include Ohio, Mississippi River valleys, and the Southwest.

• Are a past or current smoker.

• Have had other heart problems, heart attacks, or strokes.

• Have other medical conditions, including low blood cell counts, kidney or liver problems, lung disease, diabetes, HIV, or a weak immune system.

• Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.

• Have recently received or planning to receive a vaccine. You should not receive live vaccines if you take Olumiant.

• Are pregnant or planning to become pregnant. It is not known if Olumiant can harm your unborn baby. You should avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.

• Are breastfeeding or planning to breastfeed. You should not breastfeed while taking Olumiant and also for 6 days after the last dose.

Tell your doctor about all the medicines you take, including prescriptions, vitamins, over-the-counter medicines, and herbal supplements.

You should also tell your doctor if you take:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that affect your immune system

RINVOQ is a pill that is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your doctor tells you to use it. It is available in 15 mg, 30 mg, and 45 mg extended-release tablets.

Before RINVOQ treatment initiation, your doctor will perform the following evaluations:

• Active and latent tuberculosis infection evaluation – RINVOQ shouldn’t be given to patients with active tuberculosis (TB). If the latent infection is positive in patients then consider treatment for TB before RINVOQ use.

• Viral hepatitis – should also be checked before starting RINVOQ treatment. RINVOQ is not recommended in patients with active hepatitis B or hepatitis C.

• Complete blood count – RINVOQ initiation is not recommended in patients with an absolute lymphocyte count of less than 500 cells/mm3, absolute neutrophil count of less than 1000 cells/mm3, or hemoglobin level of less than 8 g/dL

• Baseline hepatic and renal function – RINVOQ initiation is not recommended for patients with severe hepatic impairment and renal impairment.

The recommended dosage of RINVOQ is 15 mg once daily.

The recommended dosage of RINVOQ is 15 mg once daily.

• Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg and Adults Less Than 65 Years of Age:
  • Initiate treatment with 15 mg once daily. If no improvement is seen, your doctor will increase the dosage to 30 mg once daily. Discontinue RINVOQ if no improvement is seen with the 30 mg dose. Use the lowest effective dose needed to maintain response.
• Adults 65 Years of Age and Older:
  • The recommended dosage is 15 mg once daily.

• Adult Patients: Induction
  • The recommended induction dose of RINVOQ is 45 mg once daily for 8 weeks.

• Adult Patients: Maintenance
  • The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if no improvement is seen with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.

The recommended dosage of RINVOQ is 15 mg once daily.

• Renal Impairment
  • Psoriatic Arthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis: No dosage adjustment is needed for patients with mild, moderate, or severe renal impairment.
  • Atopic Dermatitis: For patients with severe renal impairment, the recommended dosage is 15 mg once daily.
• No dosage adjustment is needed for patients with mild or moderate renal impairment.
• RINVOQ shouldn’t be used in patients with end-stage renal disease.
• Ulcerative Colitis:
  • For patients with severe renal impairment, the recommended dosage is:
    • Induction: 30 mg once daily for 8 weeks
    • Maintenance: 15 mg once daily
• No dosage adjustment is needed for patients with mild or moderate renal impairment.
• RINVOQ shouldn’t be used in patients with end-stage renal disease.

• Hepatic Impairment:
  • RINVOQ shouldn’t be used in patients with severe hepatic impairment.
• Psoriatic Arthritis, Rheumatoid Arthritis, Atopic Dermatitis, and Ankylosing Spondylitis: No dosage adjustment is needed for patients with mild or moderate hepatic impairment.
• Ulcerative Colitis:
  • For patients with mild to moderate hepatic impairment the recommended dosage is:
    • Induction: 30 mg once daily for 8 weeks
    • Maintenance: 15 mg once daily

Extended-release tablets: 15 mg, 30 mg, and 45 mg (

Known hypersensitivity to upadacitinib or any of the excipients in RINVOQ.

RINVOQ may cause some side effects, including:

• upper respiratory tract infections (common cold, sinus infections)
• shingles (herpes zoster)
• herpes simplex virus infections, including cold sores
• bronchitis
• nausea
• cough
• fever
• acne
• headache

• upper respiratory tract infections (common cold, sinus infections)
• acne
• herpes simplex virus infections, including cold sores
• headache
• increased blood levels of creatine phosphokinase
• cough
• allergic reactions
• inflammation of hair follicles
• nausea
• stomach-area (abdominal) pain
• fever
• increased weight
• shingles (herpes zoster)
• flu
• tiredness
• low white blood cell count (neutropenia)
• muscle pain
• flu-like illness

• upper respiratory tract infections (common cold, sinus infections)
• acne
• herpes simplex virus infections, including cold sores
• inflammation of the hair follicles
• rash
• flu
• shingles (herpes zoster)
• increased blood cholesterol levels
• increased blood levels of creatine phosphokinase
• increased liver enzyme levels
• a low number of certain types of white blood cells (neutropenia, lymphopenia).

Retinal detachment has occurred in people with atopic dermatitis treated with RINVOQ. Call your doctor right away if you experience any sudden changes in your vision during treatment with RINVOQ.

• Serious infections: RINVOQ can affect your immune system and lower the ability of your immune system to fight infections. Infections including shingles, tuberculosis (TB), and infections caused by bacteria, fungi, or viruses can occur when taking RINVOQ. Some people have also died from these infections. It can also make you more prone to get infections or may make any infections that you have worse Your doctor should test you for TB before starting RINVOQ and watch for any TB symptoms during treatment. You should not start RINVOQ unless your doctor tells you it is okay. Call your doctor right away if you show symptoms of an infection, such as:
  • fever, sweating, or chills
  • muscle aches
  • cough
  • blood in phlegm
  • shortness of breath
  • diarrhea or stomach pain
  • weight loss
  • red, warm, painful skin or sores on your body
  • urinating more often than normal or burning sensation when urinating
  • feeling tired

• Cancer and immune system problems: RINVOQ may increase your risk of skin cancers and lymphoma. People taking medicine, especially in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lung cancer and lymphoma, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer during treatment with RINVOQ.

• Blood clots: in the veins of your lungs or legs, and arteries. This may even be life-threatening and can cause death. Blood clots in the veins of legs or lungs, and arteries have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking and call your doctor right away if you have any signs and symptoms of blood clots including:
  • pain, swelling, or tenderness in one or both legs
  • sudden, unexplained chest or upper back pain
  • shortness of breath or difficulty breathing.

• Tears in the stomach or intestines: This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Call your doctor right away if you have stomach-area pain and fever that does not go away and a change in bowel habits.

• There will be a increased risk of heart attack, stroke, or death in people who are 50 years of age and above who have at least 1 heart disease risk factor and taking medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Call your doctor right away if you show symptoms of a heart attack or stroke while taking RINVOQ, including:
  • discomfort in the center of your chest
  • severe pain, pressure, tightness, or heaviness in your throat, neck, chest, or jaw
  • pain or discomfort in your back, neck, arms, jaw, or stomach
  • nausea or vomiting
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • feeling lightheaded
  • weakness on one side of your body or in one part
  • slurred speech

• Allergic reactions: While taking RINVOQ, if you have symptoms, such as swelling of your lips, tongue, or throat, rash, trouble breathing, feeling faint or dizzy stop taking RINVOQ and get emergency help right away.

• Changes in laboratory test results. Your doctor should also do blood tests before and while taking RINVOQ. You should not take RINVOQ if your white count or red blood cell is too low or your liver tests are too high. Your doctor may pause your treatment with RINVOQ because of changes in these test results. Your doctor will also check your cholesterol levels approximately 12 weeks after you start RINVOQ and when needed.

• Vaccinations: make sure to avoid the use of live vaccines with RINVOQ.

Strong CYP3A4 Inhibitors and Strong CYP3A4 Inducers

• Make sure to store RINVOQ at 36°F to 77°F (2°C to 25°C).
• Store RINVOQ in the same bottle to protect it from moisture.
• Keep RINVOQ out of reach of children.

Active ingredient: upadacitinib
Inactive ingredients: colloidal silicon dioxide, polyethylene glycol, talc, ferrosoferric oxide, mannitol, microcrystalline cellulose hypromellose, iron oxide red, polyvinyl alcohol, magnesium stearate, tartaric acid, and titanium dioxide.

Active ingredient: upadacitinib
Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose hypromellose, iron oxide red, magnesium stearate, mannitol, polyvinyl alcohol, tartaric acid, polyethylene glycol, talc, and titanium dioxide.

Active ingredient: upadacitinib
Inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide yellow and iron oxide red, magnesium stearate, microcrystalline cellulose, mannitol, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid, and titanium dioxide.